Sr. Quality Assurance Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screening.

At Thermo Fisher Scientific, you’ll do meaningful work that directly advances science and improves lives. In our BioProduction division, the products and solutions we deliver enable breakthroughs—from life-saving biologics to next-generation therapies. When our customers succeed, patients around the world benefit.

We are seeking a dynamic Sr. Quality Assurance Manager to play a critical leadership role in strengthening and stabilizing our quality organization during an important phase of growth and evolution. This is more than a functional leadership position—it’s a high-visibility opportunity to shape strategy, elevate performance, and influence outcomes across the business.

In this role, you will partner closely with executive leadership, drive operational excellence, and build a strong, resilient quality culture. You’ll gain direct exposure to senior leaders, benefit from mentorship at the highest levels, and position yourself for accelerated career growth within a global, science-driven organization.

If you are ready to step into a role where your leadership will make a measurable impact—and where your career can move to the next level—this is your opportunity to lead, influence, and grow in one of the most critical areas of our business.

Roles and responsibilities:

Leadership & Strategy

• Provide quality leadership and oversight for the greater Pharma Analytics network sites
• Develop and implement strategic quality plans aligned with company goals and operational priorities
• Serve as a member of the Pharma Analytics leadership team, actively shaping business strategy while ensuring compliance is never compromised
• Lead complex teams within a matrix environment to promote a culture of quality accountability, collaboration, and compliance

Quality, Compliance & Regulatory Oversight

• Be responsible for the quality management system, aligning with internal procedures and regulatory requirements and ensuring adherence throughout the product lifecycle
• Serve as the Single Point of Contact for quality agreements, regulatory support, product quality complaints and critical issues, mitigating risks and ensuring successful outcomes
• Coordinate compliance by ensuring site readiness for regulatory inspections, audits and oversight of industry standards
• Provide quality input for periodic business and operational forums and report out on quality health at regular intervals

Operational Excellence & Customer Focus

• Establish and manage tools for monitoring network quality trends and benchmarks, collaborating closely with Quality teams at network sites to ensure consistent and timely reporting
• Support business development activities and new product introduction by positioning Quality as a proactive strategic partner
• Ensure customer quality requirements are met through extensive knowledge of Regulated products and by maintaining strong business relationships
• Build strong, collaborative relationships with customer Quality counterparts, understanding their needs and translating them into continuous improvement initiatives

Education & Experience

• Minimum Education Required: Bachelor's degree (Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field)
• Professional certifications desired (ASQ, Lean Six Sigma, etc.)
• 7+ years of quality experience within the pharmaceutical, medical device, or regulated life sciences industry
• 5+ years of management/leadership experience required
• Experience hosting regulatory inspections and customer audits

Knowledge, Skills, Abilities

• Demonstrated ability to guide and impact operations in a matrix setting to attain desired results
• Strong communication skills: ability to engage, collaborate and influence at all levels
• Ability to think strategically with the capability to resolve technical problems using a growth mindset
• Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency
• Expert knowledge of Quality Management Systems, compliance standards (ISO, FDA, EMEA) and quality tools (FMEA, RCA, Risk Management)
• Proficient with quality management software systems
• Ability to travel up to 25%

What We Offer

Competitive Salary:

• Pay rate based on experience
• Annual performance-based bonus
• Annual merit performance-based increase

Excellent Benefits!

• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off (120 hours per year) + Designated Paid Holidays
• 401K Company Match up to 6%
• Tuition Reimbursement – eligible after 90 days!
• Employee Referral Bonus

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $140,000.00–$190,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

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